Kornimate/medical-research-clean huggingface dataset:
asthma patient education in the emergency room

Conditions: Asthma

Summary: the objective of this randomized trial is to assess the effectiveness of an intervention involving education, self-efficacy, and social support in improving quality of life outcomes among 296 adult asthma patients treated in the emergency room. the main outcome will be a comparison of within-patient change in quality of life between enrollment and 8 weeks. secondary objectives will be to assess the effectiveness of the intervention in decreasing the need for rescue inhaled beta agonists, in improving peak flow meter rates, and in decreasing the number of days lost from work or school due to asthma. these outcomes will be measured again at 16 weeks to determine if benefits are sustained. additional outcomes at 16 weeks and 1 year will be to assess the effectiveness of the intervention in decreasing urgent resource utilization for asthma and cost effectiveness.

background: many urban asthma emergency room patients lack effective self-management. most current training programs are administered in outpatient settings and have low attendance rates for emergency room patients. there is a great need to develop effective programs that can be easily administered in the emergency room for patients who, in many cases, are not present in other settings to receive education. this proposal builds on preliminary studies and is tailored to provide emergency room patients with basic education during "a teachable moment" when they may be most receptive to asthma information. design narrative: patients will be recruited from two new york city urban emergency rooms or inpatient settings and randomized to the intervention or control groups. intervention patients will receive a protocol focusing on asthma self-management, education, self-efficacy, and social support, with telephone reinforcement for 8 weeks. control patients will receive standard emergency room education about asthma.

Eligibility criteria:
inclusion criteria: * patients will be eligible if they are 18 years of age or older * fluent in english * have a known diagnosis of asthma * will receive treatment for asthma during the current hospitalization or emergency room visit. exclusion criteria: * cognitive deficits * other pulmonary diseases or severe comorbidity * do not have out-patient access to a telephone
the prevalence of bone degenerative diseases in beijing - a cross-sectional study

Conditions: Cross-sectional Study; Degenerative Disease Joint; Degenerative Disc Disease

Summary: the purpose of this observational study is to investigate the prevalence and risk factors of bone degenerative diseases


Eligibility criteria:
inclusion criteria: 1. aged 18-65 years， residents of beijing city 2. must demonstrate willingness to participate in the study by signing the written informed consent exclusion criteria: 1. subjects who had surgery on disc or knee 2. pregnent women

Keywords: prevalence bone degenerative disease
population pharmacokinetics and dose optimization of caspofungin in adolescents

Conditions: Invasive Fungal Infections

Summary: caspofungin (cas) is used to prevent and treat invasive fungal infections patients older than 3 months. however, the optimal dosing strategy of cas is lacking in adolescents from 12 to 17 years old, especially those undergoing allogeneic hematopoietic stem cell transplantation (allo-hsct), who are vulnertable to fungal infections. the study aimed to establish a population pharmacokinetic (ppk) model and assess the dosing schemes of cas in adolescents with allogeneic hematopoietic stem cell transplantation (allo-hsct).


Eligibility criteria:
inclusion criteria: * the adolescents (12 - 17 years) underwent allo-hsct * use caspofungin for the prevention or treatment of fungal infections exclusion criteria: * intolerable to caspofungin * participate into other clinical studies * there are conditions that researchers do not consider it appropriate to join the research.
soft robotic hand system for stroke rehabilitation

Conditions: Stroke

Summary: the soft robotic system could provide objective and quantifiable measures of subject performance. by combining voluntary motor intention and the robotic hand technology, the system will facilitate the recovery process of stroke patients.


Eligibility criteria:
inclusion criteria: 1. at chronic stage (6 months after the onset of stroke) with a pure unilateral motor paresis after a stroke (ischemic or hemorrhagic); 2. sufficient cognition to follow simple instructions as well as understand the content and purpose of the study; 3. able to sit up for 45 minutes (with or without assistance). exclusion criteria: 1. patients with severe dysphasia (either expressive or comprehensive) with inadequate communication; 2. any additional medical or psychological condition affecting their ability to comply with the study protocol; 3. history of other neurological disease, psychiatric disorder, including alcoholism and substance abuse.
troponin elevation in the elderly patient with hip fracture

Conditions: Hip Fracture

Summary: elevated troponin is powerful and independent adverse prognostic marker in patient with acs. however, non specific (non cardiac) troponin elevation is a common finding among hospitalized patients and worse prognosis too. the aim of this study is examine the prevalence of incidental cardiac troponin rise in a group of patient aged 65 and over admitted to geriatric department with hip fracture, and influence of troponin elevation on outcomes like acs, death, motor and cognitive function.

data collection will include epidemiological data (age, gender, living arrangement, basic functional status, fracture date, surgery date, surgery type, length of stay) as well as previous comorbidities. in addition, routine blood tests and baseline ecg will be recorded. troponin levels will be studied within 24 hours from admission, and 24 hours following surgery. in case of elevated troponin levels, ecg will be repeated, and echocardiography together with a cardiologist evaluation will be carried out. data regarding in-hospital complications, motor and cognitive function (by fim scale) and lab will be recorded. after discharge. followup will be recorded every 3 months, up to 1 year period, recoding the above mentioned data.

Eligibility criteria:
inclusion criteria: * age 65 and over with hip fracture exclusion criteria: * none
hemodynamic in postreperfusion period and functional recovery in acute ischemic stroke patients

Conditions: Acute Ischemic Stroke; Intracranial Hemorrhage

Summary: the investigators are suggtesting that lower goals of systolic blood pressure after intravenous thrombolysis may reduce the risk of hemorrhagic complications and improve functional outcomes after acute ischemic stroke.


Eligibility criteria:
inclusion сriteria: * ischemic stroke diagnosis * performed intravenous thrombolysis (including "wake up stroke") * systolic blood pressure \>140 mmhg * informed consent or council of physician agreement exclusion criteria: * absence of informed consent or council of physician agreement * pregnancy * patients participainting in other clinical trial in the last 90 days * any absolute contraindications to intravenous thrombolysis сompletion criteria: * failure to achieve hemodynamic goal for 20 minutes before the start of intravenous thrombolysis * failure to achieve hemodynamic goal for 60 minutes in first 24 hours after intravenous thrombolysis * relative arterial hypotension (sbp \<100 mmhg for 60 minutes in first 24 hours after intravenous thrombolysis) * unfavorable effect development (e.g. seizures, angioedema) * informed consent is retracted
blood sample collection to evaluate biomarkers in subjects with untreated hematologic malignancies

Conditions: Hematologic Malignancy

Summary: the primary objective of this study is to obtain de-identified, clinically characterized, whole blood specimens to evaluate biomarkers associated with cancer for diagnostic assay development.

subjects will have been recently diagnosed with an untreated hematologic malignancy. subjects will have a blood sample collected at enrollment and provide medical history prior to initiation of treatment. there will be no further follow-up.

Eligibility criteria:
inclusion criteria: * subject is male or female ≥ 18 years of age. * subject has an untreated hematologic malignancy. * subject understands the study procedures and is able to provide informed consent to participate in the study and authorization for release of relevant protected health information to the study investigator. exclusion criteria: * any previous cancer diagnosis within the past 5 years (with the exceptions of basal cell or squamous cell skin cancers). * chemotherapy and/or radiation therapy within 5 years prior to enrollment/sample collection. * any treatment for the primary malignancy. subject may not have started neo-adjuvant chemotherapy, neo-adjuvant radiation therapy, immunotherapy or other treatment prior to blood sample collection. * less than 3 days between fine needle aspiration (fna) of target pathology and blood collection. * less than 7 days between biopsy (other than fna) of target pathology and blood collection. * iv contrast (e.g. ct and mri) within 1 day \[or 24 hours\] of blood collection. * individual has a condition the investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk.

Keywords: blood draw sample collections
quinagolide vaginal ring on lesion reduction assessed by mri in women with endometriosis/adenomyosis

Conditions: Endometriosis

Summary: this will be a randomized, double-blind, placebo-controlled, proof-of-mechanism phase 2 trial investigating the effect of quinagolide extended-release vaginal ring on reduction of lesions assessed by high-resolution magnetic resonance imaging in women with endometrioma, deep infiltrating endometriosis, and/or adenomyosis.


Eligibility criteria:
inclusion criteria: 1. pre-menopausal women between the ages 18-45 years (both inclusive) at the time of signing the informed consent 2. body mass index (bmi) of 18-35 kg/m2 (both inclusive) at screening 3. confirmation of deep infiltrating endometriosis (die), endometrioma or adenomyosis by high-resolution mri at screening 4. transvaginal ultrasound (tvu) documenting a uterus with no abnormalities of endometrium and presence of at least one ovary with no clinically significant abnormalities at screening. note that presence of uterine fibroids are not exclusionary but presence of any submucosal fibroids or polyps are exclusionary 5. willing and able to use a non-hormonal single-barrier method (i.e. condom) for contraception from the start of screening to the end-of-treatment. this is not required if adequate contraception is achieved by vasectomy of the male sexual partner, surgical sterilisation (e.g. tubal ligation and blockage methods such as essure) of the subject, or true abstinence of the subject (sporadic sexual intercourse with men requiring condom use) 6. willing to avoid the use of vaginal douches or any other intravaginally administered medications or devices (except for tampons) from randomization to the end of treatment exclusion criteria: 1. use of depot medroxyprogesterone acetate (mpa) within 10 months prior to the screening visit. 2. use of gonadotropin-releasing (gnrh) agonists (3-month depot) or dopamine agonists within 6 months prior to the screening visit. 3. use of gnrh agonists (1-month depot or nasal spray), gnrh antagonists, aromatase inhibitors, danazol, birth control implants (e.g. nexplanon), progestogen or levonorgestrel releasing intrauterine device (iud) within 3 months prior to the screening visit. 4. use of hormonal contraceptives (including combined oral contraceptive pill, transdermal patch, and contraceptive ring) within 1 menstrual cycle prior to the screening visit. 5. contraindications to mri such as having internal/external metallic devices and/or accessories (e.g. cardiac pacemakers and leg braces)

Keywords: endometrioma adenomyosis deep infiltrating endometriosis
cnp-103 in adolescent and adult subjects ages 12-35 with recently diagnosed (within 6 months) stage 3 type 1 diabetes (t1d)

Conditions: Type 1 Diabetes Mellitus; T1D; T1DM; T1DM - Type 1 Diabetes Mellitus; Type 1 Diabetes in Adolescence; Type 1 Diabetes in Children; Type 1 Diabetes (Juvenile Onset); Type 1 Diabetes; Type 1 Diabetes Patients; Type 1 Diabetes Mellitis

Summary: this study is a phase 1b/2a first-in-human (fih) clinical trial to assess the safety, tolerability, pharmacodynamics (pd), and efficacy of multiple ascending doses of cnp-103. the approximately 208-day study consists of a screening period (28 days), treatment period (90 days), and post-dose evaluations (90 days).


Eligibility criteria:
inclusion criteria: * 1. subjects who are willing and able to provide institutional review board (irb) approved written informed consent and privacy language as per national regulations. 2. men and non-pregnant, non-breast-feeding women ages 12-35 years inclusive. 3. documented diagnosis of t1d within 180 days prior to study enrollment according to american diabetes association \[ada\] criteria. 4. subjects with a peak stimulated c-peptide of \>0.2 nmol/l measured from a mixed meal tolerance test (mmtt). note: this test result may be obtained from an mmtt conducted within 1 month of planned first dose. 5. for subjects on any medication used to treat the symptoms of t1d (e.g., corticosteroids), subjects must be on a stable dose for a minimum of 1 month prior to enrollment and must agree not to increase their dose from screening visit through end of study visit unless reviewed and approved by the medical monitor and the site investigator exclusion criteria: * subjects who have used the following medications: a. within 5 half-lives or 90 days prior to first dose, whichever is shorter: i. oral immunomodulators: (i.e., cyclosporin, azathioprine, methotrexate) ii. b cell depleting immunotherapy (e.g., rituximab) iii. other anti-diabetic agents besides insulin (e.g., verapamil). insulin is allowed if on a stable dose for 30 days prior to the day 1 dose). b. within 6 months prior to first dose: i. t cell modifying immunotherapy (e.g., abatacept, etanercept, ustekinumab) within 6 months prior to the first dose c. within 12 months prior to first dose: i. t cell depleting immunotherapy (e.g., teplizumab) within 12 months prior to the first dose d. exclusion of additional immunomodulation will be at the discretion of the medical monitor and study site investigator. 2. subjects who present with diabetic ketoacidosis (dka) at the time of diagnosis. note: any mmtt must be performed no sooner than 2 weeks and up to 4 weeks after dka diagnosis.

Keywords: diabetes t1d stage 3 adolescents adults t1dm newly diagnosed recently diagnosed
rivaroxaban versus aspirin in secondary prevention of stroke and prevention of systemic embolism in patients with recent embolic stroke of undetermined source (esus)

Conditions: Stroke

Summary: this is a study in patients who recently had a brain attack (stroke) and in whom no clear cause of the stroke could be identified. these strokes are likely due to a blood clot and therefore, can be called embolic stroke of undetermined source. the abbreviation is esus. the study will compare 2 blood thinners. patients will be randomly assigned to either rivaroxaban 15 mg or aspirin 100 mg and the study is intended to show, if patients given rivaroxaban have fewer blood clots in the brain (stroke) or in other blood vessels.


Eligibility criteria:
inclusion criteria: * recent esus (between 7 days and 6 months), defined as: * recent ischemic stroke (including transient ischemic attack with positive neuroimaging) visualized by brain imaging that is not lacunar, and * absence of cervical carotid atherosclerotic stenosis\> 50% or occlusion, and * no atrial fibrillation after ≥ 24-hour cardiac rhythm monitoring, and * no intra-cardiac thrombus on either transesophageal or transthoracic echocardiography, and * no other specific cause of stroke (for example, arteritis, dissection, migraine/vasospasm, drug abuse) exclusion criteria: * severely disabling stroke (modified rankin score ≥4) * indication for chronic anticoagulation or antiplatelet therapy * estimated glomerular filtration rate (egfr) \< 30 ml/min/1.73 m\^2

Keywords: rivaroxaban xarelto aspirin acetylsalicylic acid (asa) oral anticoagulant blood thinner stroke ischemic stroke cryptogenic stroke embolic stroke of undetermined source esus transient ischemic attack thromboembolism cerebrovascular disease
omega-3/omega-6 fatty acids for attention-deficit/hyperactivity disorder (adhd): a trial in children and adolescents

Conditions: ADHD; Reading/Writing Disorder

Summary: objective: to assess whether supplementation with omega 3/6 fatty acids (eye q®) was effective in the treatment of adhd and its diagnostic subtypes and comorbid conditions, in children and adolescents. method: randomized placebo-controlled one-way crossover trial with 75 children and adolescents aged 8-18 years receiving omega 3/6 or placebo for three months followed by 3 months with omega 3/6 for all. adhd symptoms were measured with the investigator-rated adhd rating scale-iv-parent version and the clinical global impression (cgi) scale of symptom severity and impairment.

the study design is a randomised, double-blind placebo-controlled trial with a total duration of 6 months. 50-100 children and adolescents, aged 8-18 years, who meet the dsm-ivô criteria for attention-deficit/hyperactivity disorder (adhd) of any subtype will be given the opportunity to participate. the study comprises 2 study periods. study period i this is an assessment/evaluation and drug washout phase of up to 1-3 months for those patients taking any medication excluded by the protocol. study period ii participants will be randomised to 3 months of treatment with a fixed dose of 6 capsules per day of eyeq, divided in two daily doses, to supply 558 mg epa, 174 mg dha and 60 mg gla daily, or to placebo. identical capsules containing olive oil will be used as placebo. randomisation will be organized by equazen uk ltd, who will prepare randomisation numbers to be sent out to the investigation centre. at 3 months a one-way treatment crossover of the placebo-group to active treatment will be made so that both patient groups will receive eyeq for the remaining 3-month period. compliance will be ascertained through bi-weekly telephone contacts and at each visit. compliance is defined as taking the prescribed dosage \>70% of the days in a visit interval. neuropsychiatric assessment: dsm iv checklist adhd-rating scale iv - parent:inv clinical global impression (cgi) scale gaf-scale ftf teacher questionnaire snap-iv teacher questionnaire brown's add teacher scale neuropsychological assessment: wisc-iii® or wais-iii® vmi digit span span-board task qb-test brown's add self report cdi (children's depression inventory) five to fifteen (ftf) parent questionnaire brown's add parent scale snap-iv parent questionnaire nijmegen questionnaire hufa deficiency questionnaire reading and writing tests: dls etc

Eligibility criteria:
inclusion criteria: * patients aged 8-18 years * met dsm-iv criteria for a diagnosis of adhd of any subtype exclusion criteria: * autism * psychosis * bipolar disorder * mental retardation * uncontrolled seizure disorder * hyper- or hypothyroidism * significant other medical conditions * weight below 20 kg * alcohol or drug abuse or the use in the past three months of any psychoactive drugs or omega 3 preparations

Keywords: attention-deficit/hyperactivity disorder omega 3/6 fatty acids developmental coordination disorder reading/writing difficulties.
quality of the management of diabetes in elderly people with dementia in france

Conditions: Alzheimer Disease

Summary: along with population ageing, the association of chronic conditions such as alzheimer's disease and related syndromes (adrs) and diabetes mellitus is increasing in clinical practice. according to adrs severity, guidelines of diabetes care may be adapted for a personalized monitoring and treatment. the consequences on diabetes complications are not known and can also threaten dementia progression. based on a nationwide healthcare reimbursement database, the present study aimed to compare diabetes care and the incidence of acute complications between patients with or without adrs, in a longitudinal perspective focusing on the pivotal period of adrs identification by the healthcare system.


Eligibility criteria:
inclusion criteria: * individuals with a first adrs criterion in 2011 or 2012, * prevalent diabetes mellitus, defined by a ltd with icd-10 codes of diabetes mellitus ("e10-e14"). * at least one reimbursement in the year preceding inclusion.

Keywords: diabetes mellitus alzheimer disease or related disorders
diabetes mellitus type 2 basal insulin dosing requirements study

Conditions: Type 2 Diabetes Mellitus

Summary: the main purpose of this study is to determine the number of daily basal insulin rate changes that are needed to achieve short-term near normal glucose control in insulin pump patients with type 2 diabetes

subjects will be taught cho counting after which they will be introduced to an insulin pump. they will wear the insulin pump for three weeks to adjust to the pump and its functions. then the subject will wear a continuous glucose monitoring system to determine rate changes needed to achieve short-term near normal glucose control. the primary endpoint is what are the mean number of changes in the basal infusion rate and what are the mean differences and mean duration of these changes. the secondary endpoint is what mathematical formulas describe the relationship between the dosing factors and do they significantly differ from those previously established by king and armstrong.

Eligibility criteria:
inclusion criteria: * type 2 diabetes \> 3month duration * age 18 * hb a1c \<12% * on any hypoglycemic therapy including insulin for 5 patients and 5 patients naive to insulin and failing oral treatment * normal creatine * negative for gad antibodies * smbg \>4/d and willing/able to comply with study requirements * demonstrated adherence to visits and instructions. exclusion criteria * severe hypoglycemic during the last month * severe cardiac, pulmonary or cerebral disease * demonstrated non compliance with clinical recommendations * pregnancy, nursing or women who could potentially become pregnant * presence of physical, psychological or cognitive impairments that would interfere with adherence to an intensive insulin therapy program or compliance with dietary, diary keeping or maintenance of cgm sensor or pump

Keywords: insulin pump dm type 2 cgms basal rate
cologne cohort of neutropenic patients (coconut)

Conditions: Hematological Malignancies; Cancer; Chemotherapy; Neutropenia; Immunosuppression

Summary: the cologne cohort of neutropenic patients (coconut) is a non-interventional cohort study assessing risk factors, interventions, and outcome of immunosuppressed patients with or without opportunistic infections.

this prospective cohort was established with the aim of a comprehensive data collection of all patients developing neutropenia after receiving chemotherapy for any kind of malignant disease, treated in the university hospital of cologne.

Eligibility criteria:
inclusion criteria: * immunosuppressed patients exclusion criteria: * none

Keywords: hematological malignancies cancer chemotherapy anti-infectives treatment outcome